FDA 510(k) Application Details - K053599

Device Classification Name Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

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510(K) Number K053599
Device Name Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Applicant SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH, WA 98029 US
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Contact AL VAN HOUDT
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Regulation Number 868.1700

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Classification Product Code CBR
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Date Received 12/23/2005
Decision Date 04/19/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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